ServiceUpdated on 31 July 2025
U–Mexico Contract Analytical & Stability Testing for Pharma & Biotech
About
Partner with a Mexican public biotech research center to accelerate your Mexico market entry. We deliver contract analytical chemistry and microbiology services for pharma and biotechs: method development/validation, impurity profiling, and stability studies aligned with international guidelines. Core instrumentation includes HPLC, LC-MS/MS, GC-MS, ICP-OES, and spectroscopy; plus PCR/qPCR and microbiological assays for quality and safety.
What you get
-
Fit-for-purpose methods and validated reports (EN/ES).
-
Data packages suitable for COFEPRIS submissions and tech transfer.
-
Traceable raw data and clear SOPs for reproducibility.
How we work
-
Rapid scoping call (EU-friendly hours) and NDA/MTA as needed.
-
Tech transfer and sample plan; defined milestones and turnaround.
-
Execution with QA review and interim readouts.
-
Final dossier: raw data, statistical analysis, and regulatory-ready report.
Add-ons
-
Pilot-scale fermentation and microencapsulation for scale-up.
-
Tailored training for technical teams and practical consultancy (process, quality, and regulatory in Mexico).
Organisation
Similar opportunities
Project cooperation
Evaristo Urzua
Tech Transfer Liaison at CIATEJ
GUADALAJARA, JALISCO, Mexico
Expertise
Evaristo Urzua
Tech Transfer Liaison at CIATEJ
GUADALAJARA, JALISCO, Mexico
Service
Registration of Pharmaceutical Products
María de la Luz Lara Méndez
CEO & Co-founder at Udelá Global
Ciudad de México, Mexico